MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
|
Back to Search Results |
|
Model Number 3058 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Pain (1994)
|
Event Date 04/08/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
B3: date is approximate.Year is confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 978b128 (lot: va2cb1m); product type: 0200-lead; implant date (b)(6) 2021; explant date (b)(6) 2022.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that the patient was in so much pain in the beginning that the doctor had to rewire the wire to the other side.Patient had a second surgery on it.The pain started happening within the first year.The doctor moved the wire around and it was fine.
|
|
Event Description
|
No new information.
|
|
Manufacturer Narrative
|
Continuation of d10: product id: 978b128, lot# va2cb1m, implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: lead.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Search Alerts/Recalls
|
|
|